WhatDoTheyKnow · 2020. 11. 30. · Covering Letter 18 May 2011 Evidence of insurance or indemnity...

NRES Committee London - Fulham

Charing Cross Hospital Room 4W/12, 4th Floor Charing Cross Hospital

Fulham Palace Road London

W6 8RF Telephone: 020 3311 Facsimile: 020 3311

Prof Katya Rubia Institute of Psychiatry Dep Child & Adolescent Psychiatry De Crepigny Park SE5 8AF 29 June 2011 Dear Prof Rubia Study Title: Structural and functional magnetic resonance imaging

of childhood physical abuse REC reference number: 11/LO/0799 Protocol number: 1

The Research Ethics Committee reviewed the above application at the meeting held on 20 June 2011. Thank you for attending to discuss the study and please thank Dr and Dr for attending also. Documents reviewed The documents reviewed at the meeting were: Document Version Date

Advertisement 1 13 April 2011

Covering Letter 18 May 2011

Evidence of insurance or indemnity 09 July 2010

GP/Consultant Information Sheets 1 13 April 2011

Investigator CV

Letter from Sponsor 03 March 2011

Letter of invitation to participant 1 13 April 2011

Other: Letter of support from Kids Company 18 October 2011

Other: Research Funding agreement (Kids Company) 04 February 2010

Other: ICU Youth Version

Other: ICU Parent Version

Other: Becks Depression Inventory

Other: Wechsler Abbreviate Scale of Intelligence

Other: Edinburgh Handedness Inventory

Other: CVs for research team inc student

Other: Response to earlier rejection 11/LO/0409 27 April 2011

Other: Response to earlier rejection 10/H0807/56 06 March 2011

Participant Consent Form: Parent or guardian fMRI 1 13 April 2011

Participant Consent Form: Adolescent fMRI 1 13 April 2011

Participant Consent Form: Adolescent DNA 1 13 April 2011

Participant Consent Form: Parent or guardian DNA 1 13 April 2011

Participant Information Sheet: Adolescent Control 1 27 April 2011

Participant Information Sheet: Adolescent Psychiatric Control 1 27 April 2011

Participant Information Sheet: Adolescent Physically Abused & Psychiatric Patient

1 27 April 2011

Participant Information Sheet: Adolescent Physically abused only 1 27 April 2011

Protocol 1 27 April 2011

Questionnaire: Conners' Parent Rating Scale - Revised

Questionnaire: CTQ

Questionnaire: Development and Well-being Assessment - 11-17 year olds

Questionnaire: Development and Well-being Assessment - Parent Interview

Questionnaire: Family Relationships in Childhood

REC application 80156/215084/1/969

18 May 2011

Referees or other scientific critique report 07 September 2010

Provisional opinion

A. The Committee welcomed the researchers and informed them that two coordinators and observers were present.

B. The Committee asked the researchers to confirm if left-handedness was an exclusion criterion and explain why. Professor Rubia stated it was an exclusion criterion qualifying that there is evidence to show that left-handed and right-handed people use different sides of their brain. The Committee queried when this would be tested as the application suggests that a participant will be recruited into the study and then tested using the Edinburgh Handedness Inventory questionnaire. Professor Rubia explained that the questionnaire would be used to double check once participants had been recruited into the study but initially they would be asked.

C. The Committee asked if the information sheet for 14-18 year olds would be given to all participants. Professor Rubia stated it would be. The Committee asked the researchers why an information sheet for parents/carers had not been submitted. Professor Rubia acknowledged that this was an error and advised the Committee that one would be produced.

D. The Committee queried the procedure that would be followed if it were discovered that a parent asked to give consent to the study was involved in the child’s abuse. Professor Rubia acknowledged that this was a very difficult area and assured the Committee that an experienced child psychologist was on hand if needed. Dr continued that if there were signs of abuse the child’s needs and safeguarding would come before the research although it would be very rare for abused children to be still living with their parents if they were initially involved in it.

E. The Committee queried the length of time for a child with behavioural problems to spend in the MRI scanner. Professor Rubia advised the Committee that they would not scan anyone below 10 year of age and acknowledged that children with ADHD are less tolerant but if they are uncomfortable they can have breaks.

F. The Committee asked the researchers to clarify if a MR safety officer had reviewed the application and confirmed the MRI is safe for the proposed length

of time and level as there may be noise and tissue warming effects. Professor Rubia stated that internal meetings had taken place with a physicist and they had confirmed they were happy with the project further assuring the committee that headphones and earplugs would be provided to help reduce the noise effects, and that a physicist had been assigned to attend every scan.

The Committee is unable to give an ethical opinion on the basis of the information and documentation received so far. Before confirming its opinion, the Committee requests that you provide the further information set out below. The Committee delegated authority to confirm its final opinion on the application to the Chair. Further information or clarification required

1. The Committee would like confirmation that all investigators involved in the study are suitably trained in Child Protection, and where available certificates to be produced.

2. A separate Information sheet and Consent form for Parents/Carers should be produced for review.

3. The Committee would also like to review a dose calculation and risk estimation from an MR safety officer or Physicist to reassure the Committee that the amount of energy delivered by the scanner to the children taking part is within safe limits.

4. The reference to ‘his DNA’ in point 4 of the consent form should be amended to ‘my DNA’.

5. The Committee would like the patient information sheet to state that if drugs are found in a participant’s urine he/she will be referred to other services and clearly delineated that their confidentiality will be broken.

If you would find it helpful to discuss any of the matters raised above or seek further clarification from a member of the Committee, you are welcome to contact

at @imperial.nhs.uk.

When submitting your response to the Committee, please send revised documentation where appropriate with tracked changes and giving revised version numbers and dates.

�

If the committee has asked for clarification or changes to any answers given in the application form, please do not submit a revised copy of the application form; these can be addressed in a covering letter to the REC. The Committee will confirm the final ethical opinion within a maximum of 60 days from the date of initial receipt of the application, excluding the time taken by you to respond fully to the above points. A response should be submitted by no later than 27 October 2011. Membership of the Committee The members of the Committee who were present at the meeting are listed on the attached sheet.

Statement of compliance The Committee is constituted in accordance with the Governance Arrangements for Research Ethics Committees (July 2001) and complies fully with the Standard Operating Procedures for Research Ethics Committees in the UK. 11/LO/0799 Please quote this number on all correspondence Yours sincerely Dr Chair Email: @imperial.nhs.uk Enclosures: List of names and professions of members who were present at the

meeting and those who submitted written comments. Copy to: , Institute of Psychiatry

NRES Committee London - Fulham

Attendance at Committee meeting on 20 June 2011 Committee Members: Name Profession Present Notes

Retired Lawyer Yes

Prof Anthropologist Nurse No

Dr Retired Scientist Yes

Hospital Chaplain Yes

Retired academic Yes

Dr Director of Communications and Public Affairs

Yes

Dr Physician Yes

Pharmacist Yes

Dr General Practitioner No

Dr Consultant Physician Yes

Dr Paediatrician Yes

Dr Physician Yes

Dr Psychiatrist Yes

Surgeon Yes

Lay Member Yes

Occupational Therapist No

Clinical Trials Centre Manager

Yes

Dr Radiologist Yes

Also in attendance:

Name Position (or reason for attending)

Coordinator

PRS Co-ordinator

Medical Student (Observer)

Medical Student (Observer)

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Katya Rubia, PhD, Prof of Cognitive Neuroscience Head, Section of Developmental Neuroimaging Dep. of Child Psychiatry/MRC Centre for Social Genetic and Developmental Psychiatry P0 Box 46 De Crespigny Park Denmark Hill London SE5 8AF T: +44 (0)20 7848 0463 F: +44 (0)20 7708 5800 www.iop.kcl.ac.uk [email protected] 30/06/2011 Dear Committee Members I herewith attach my responses to the comments from the NRES Committee London- Fulham Response to the comments of the Committee: Nr 11/LO/0799 on 20 June 2011 1. The Committee would like confirmation that all investigators involved in the study are suitably trained in Child Protection, and where available certificates to be produced. Dr and the part-time Clinical Psychiatrist are experienced child psychiatrists and, as such, have carried out all the relevant training, including Child Safeguarding and Protection (does have a certificate we can send? Katya- do you have any training/certificates I should mention here?). Dr has attended the South London and Maudsley NHS Foundation Trust Safeguarding Children Course Levels I, II, and III (Proof of completing Level I online and certificate for Levels II and III enclosed) and Ms

is booked onto this same course on 4th July 2011 and will complete the training before the research commences. 2. A separate Information sheet and Consent form for Parents/Carers should be produced for review. We apologise for the omission to include the adult information sheets. We originally had one single information sheet for adults, but have now also produced 4 different versions for the parents of the 4 different groups, in line with the 4 different information sheets for

participants. We thus enclose parent/carer information sheets for each of the four participant groups. 3. The Committee would also like to review a dose calculation and risk estimation from an MR safety officer or Physicist to reassure the Committee that the amount of energy delivered by the scanner to the children taking part is within safe limits. A dose calculation and risk estimation by an MR physicist are enclosed. We also report on noise reduction and potential tissue warming effects. 4. The reference to ‘his DNA’ in point 4 of the consent form should be amended to ‘my DNA’. The DNA consent form now been altered as requested and is enclosed with tracked changes and revised version number and date. 5. The Committee would like the patient information sheet to state that if drugs are found in a participant’s urine he/she will be referred to other services and clearly delineated that their confidentiality will be broken. This has now been added to the four participant information sheets. The amended versions are enclosed with tracked changes and revised version number and date. Best wishes Katya Rubia

Katya Rubia, PhD, Prof of Cognitive Neuroscience Head, Section of Developmental Neuropsychology & Neuroimaging Dep. of Child Psychiatry/MRC Centre for Social Genetic and Developmental Psychiatry P0 Box 46 De Crespigny Park Denmark Hill London SE5 8AF T: +44 (0)20 7848 0463 F: +44 (0)20 7708 5800 www.iop.kcl.ac.uk [email protected] 05/07/2011 Dear Committee Members Thank you for considering pour REC application and for your response and constructive comments. I herewith attach our responses to the comments from the NRES Committee London- Fulham Response to the comments of the Committee: Nr 11/LO/0799 on 20 June 2011 1. The Committee would like confirmation that all investigators involved in the study are suitably trained in Child Protection, and where available certificates to be produced. Dr is an experienced child psychiatrist and, as a consultant in CAMHS, has undertaken mandatory Level 3 Safeguarding training (certificate enclosed). The part-time clinical psychiatrist has not yet been appointed but we will ensure that they have also completed Level 3 Safeguarding training. Given that the yet to be appointed clinician will be an experienced child psychiatrist, he/she will have had done the safeguarding training which is mandatory in this country. If for any reason this is not the case we will make sure she/he will undergo the course before starting to work on the project. However, we will appoint someone with experience and hence safeguarding certificate. Dr has attended the South London and Maudsley NHS Foundation Trust Safeguarding Children Course Levels I, II, and III (Proof of completing Level I online and certificate for Levels II and III enclosed) and Ms has completed South London and Maudsley NHS Foundation Trust Safeguarding Children Course Levels I, II (certificate enclosed) and will be completing Level III next month, and she will not start participating in the research until she has finished level

III training. Professor Katya Rubia will be overseeing the project but will not have direct contact with the participants and has, therefore, not completed Safeguarding training. 2. A separate Information sheet and Consent form for Parents/Carers should be produced for review. We have enclosed parent/carer information sheets for each of the four participant groups. 3. The Committee would also like to review a dose calculation and risk estimation from an MR safety officer or Physicist to reassure the Committee that the amount of energy delivered by the scanner to the children taking part is within safe limits. A dose calculation and risk estimation by our MR physicist are enclosed. 4. The reference to ‘his DNA’ in point 4 of the consent form should be amended to ‘my DNA’. The DNA consent form has now been altered as requested and is enclosed with tracked changes and revised version number and date. 5. The Committee would like the patient information sheet to state that if drugs are found in a participant’s urine he/she will be referred to other services and clearly delineated that their confidentiality will be broken. This has now been added to all of the participant and parent information sheets. The amended versions are enclosed with tracked changes and revised version number and date. Best wishes Katya Rubia

Consent form Adolescent FMRI 13/04/2011

Study Number: Patient Identification Number for this study: Ethical application number:

CONSENT FORM (Adolescent fMRI)

(version 1 17/06/2011)

Title of Project: NEUROIMAGING CORRELATES OF PHYSICAL CHILD ABUSE Name of Researcher: Dr Heledd Hart/Prof Katya Rubia Please initial box 1 I confirm that I have read and understand the information sheet dated

(version ………………..) for the above study and have had the opportunity to ask questions

2 I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected

3 I understand that sections of any of my medical notes may be looked at

by a clinical radiographer and by the researchers involved in the study. I give permission for these individuals to have access to my records.

4

I agree to take part in the scanning study 5

I agree that the information from social services about me can be accessed by the researcher

6

I agree that my GP will be contacted if any abnormalities are detected in my brain

7

I agree that my GP will be contacted regarding participation in this study

Consent form Adolescent FMRI 13/04/2011

8

I agree that my brain imaging data are being used in an anonymised form in future research

9

I would like to have written feedback on the study findings Name of Adolescent Date Signature _________________________ ________________ ____________________ Name of Person taking consent Date Signature (if different from researcher)

I confirm that I have explained the study to the participants in all relevant details and have answered any questions honestly and fully _________________________ ________________ ____________________ Researcher Date Signature

1 for patient; 1 for researcher; 1 to be kept with hospital notes

Consent form Parent fMRI


CONSENT FORM (parent or guardian fMRI)

(Version 1 17/06/2011)

Title of Project: Neuroimaging of physical child abuse Name of Researcher: Dr Heledd Hart/Prof Katya Rubia Please initial box 1 I confirm that I have read and understand the information sheet dated


2 I understand that my son’s participation is voluntary and that he is free to withdraw at any time without giving any reason, without his medical care or legal rights being affected

3 I understand that sections of any of his medical notes being looked at by a clinical radiographer. I give permission for this individual to have access to his records.

4 I agree for my son to take part in the scanning study 5 I agree that information from social services about my son can be

accessed by the researcher 6 I agree that my son’s GP will be contacted if anything abnormal is

detected in this brain scan 7 I agree that my son’s brain imaging data will be stored anonymously

for future research 8 I would like to have written feedback on the study findings

Consent form Parent fMRI

________________________ ________________ ____________________ Name of Parent/Guardian Date Signature _________________________ ________________ ____________________ Name of Person taking consent Date Signature (if different from researcher)



Consent form adolescent participant DNA


CONSENT FORM (Adolescent DNA)

(Version 2 30/06/2011)

Title of Project: Neuroimaging correlates of physical child abuse Name of Researcher: Dr Heledd Hart/Prof Katya Rubia Please initial box 1 I confirm that I have read and understand the information sheet dated


2 I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected

3 I understand that sections of any of my medical notes being looked at by a clinical radiographer. I give permission for this individual to have access to my records.

4 I agree that I will give a sample of his my DNA through a cheek swab 5

I agree that my GP will be contacted regarding participation in this study

6

I would like to have written feedback on the study findings

7

I agree that my DNA will be stored in a DNA databank at the Institute of Psychiatry anonymously for future research

Consent form adolescent participant DNA

________________________ ________________ ____________________ Name of Patient Date Signature _________________________ ________________ ____________________ Name of Person taking consent Date Signature (if different from researcher)


1 for participant; 1 for researcher; 1 to be kept with hospital notes

Consent form parents DNA


CONSENT FORM (parent or guardian DNA)

(Version 1 17/06/2011)

Title of Project: Neuroimaging correlates of physical child abuse Name of Researcher: Dr Heledd Hart/Prof Katya Rubia Please initial box 1 I confirm that I have read and understand the information sheet dated


2 I understand that my son’s participation is voluntary and that he is free to withdraw at any time without giving any reason, without his medical care or legal rights being affected

3 I understand that sections of any of his medical notes being looked at by a clinical radiographer. I give permission for this individual to have access to his records.

4

I agree that my son will give a sample of his DNA through a cheek swab

5

I agree that my son’s GP will be contacted regarding participation in this study

6

I would like to have written feedback on the study findings

Consent form parents DNA

7

I agree that my son’s DNA will be stored in an anonymous way in a DNA databank at the Institute of Psychiatry

________________________ ________________ ____________________ Name of Patient Date Signature _________________________ ________________ ____________________ Name of Person taking consent Date Signature (if different from researcher)



Information Sheet Neurofeedback ADHD Child 1/2/2012

You are being invited to take part in some research the Institute of Psychiatry, King’s College London. Before you decide to take part you should understand why this research is being done and what you will have to do. Please take the time to read the information carefully and talk about it with your family, friends or doctor if you want to. Ask us if there is anything that you do not understand and take your time in deciding whether or not you want to take part. What is the purpose of the study? The aim of this study is to test a new treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). The best current treatment for children with ADHD is with medication, i.e. with stimulant drugs. However, there are important side effects such as problems with growth, sleep and loss of appetite and there is little evidence for long-term beneficial effects of these stimulant drugs. This research is therefore trying to establish a new treatment that has shown to work well in children with ADHD and that has no side effects, called Neurofeedback.

With this new treatment children with ADHD will learn to self-regulate their own brain activation using a scanner called magnetic resonance imaging that measures the activity of your brain. You will learn to change your own brain’s activity in a playful way, while playing on a computer game that is connected to your brain activity. You will see a helicopter on the screen and everytime you learn to increase the activity in certain parts of your brain the helicopter will fly. This method has been shown to be very effective in improving ADHD symptoms, using a more basic imaging technique, electrophysiology, but we expect that NF using the MRI scanner will have better effects as the FMRI imaging technique has a far better spatial resolution and will be better able to target the key regions that are abnormal in ADHD children. This novel treatment, if successful, will benefit all ADHD children as it would provide them with a new treatment that has no side effects and that has so far been shown to have long-lasting effects, which is not the case with stimulant medication. Stimulant medication is not effective when discontinued, as it is based on an external neurochemical stimulation of brain regions. However, NF has been shown to be long-lastingly effective for up to 2 years, as it is based on a learned self-regulation of the brain, which appears to change the brain lastingly, rather than an externally induced stimulation, as is the case with stimulants.

So, there will be 4 groups of adolescents in this study

1) Adolescents with child abuse and no behavioural problems 2) Adolescents with child abuse and behavioural problems 3) Adolescents with behavioural problems and no child abuse 4) Adolescents who have no child abuse and no behavioural problems.

We will also gather information on specific genes via simple cheek swabs from these 4 groups. This is because studies have shown that specific genes are associated with worse behavioural problems in children with childhood abuse. If we would find that the presence of these genes leads to greater

VOLUNTEER INFORMATION SHEET: Child

Please read this if you think you might want to take part in our research

It is completely up to you

Study Title: Neurofeedback in children with ADHD

(version 1 of 1/2/2012)

Information Sheet Adolescent Physically Abused and Psychiatric Patient Page 2 05/02/2016

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brain abnormalities then we would be able to tell in the future which children need more intensive treatment or more intensive attention based on their gene make-up. We hope that this research will help us to better understand the relationship between early childhood maltreatment and the effects this has on the young brain. This is important as better understanding of the effect of child abuse on the brain may help in the future to develop treatment and hopefully lead to better policies of prevention of child abuse.

Why have I been chosen? We ask you to be part of this research because you are a boy between 14 and 18 years old who belongs to group 2) of the groups mentioned above, i.e. you are an adolescent who has been physically abused in childhood and have some behavioural problems. We will ask 100 boys who belong to either group 1-4 to take part in the study. So when we have finished the study we will be able to compare between the brains of these 4 groups of adolescents to find out what is different between the activity and the structure of the brain in adolescents who have been physically abused and adolescents who have not been abused, controlling for the effects of behavioural problems. Do I have to take part? No. It is up to you whether you take part or not. If you do want to take part you will be asked to sign a form to say that you would like to take part. Once you have signed this form, you can still change your mind at any time and you do not have to say why. If you decide to change your mind, this will not affect your treatment in any way. What am I asked to do? We will ask you to participate in a brain scan on a MRI scanner. The brain scan is perfectly safe, does not hurt and no side effects have ever been reported. You will be in the scanner for about 1 hour and 30min. First, we will take a picture of your brain while you are doing nothing. During this time you can watch a movie that you will be able to choose yourself. Then, while you are still in the scanner, you will have to do 4 short computer tests of 10 min each. Below is a picture of the scanner. Please note that you will be lying in the scanner during the entire time with a button box and you will be able to see the screen (shown in the picture) through a mirror that is attached in the ceiling of the scanner. We will show you how this works before you are being scanned on a dummy scanner.

Apart from the scan, we will also ask you to give us a sample of your DNA. Everybody in the world has molecules that are called DNA. DNA are our genes and they decide everything about us like our hair colour, our eye colour and also our behaviours. Below is a picture of what your DNA looks like.

The patterns of these genes are very important in making us who we are.


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We would also like to take a sample of your DNA so that we can look to see if different patterns of genes are related to the way the brain functions or to the way the brain is built. This is important as it has been shown that specific genes make people more susceptible to brain differences after they have been abused while other people with different genetic make-up are more resilient and remain unaffected by their early life experience. To find out which genes are associated with susceptibility to brain abnormalities in people with abuse will help us in the future to know which people are in more need of treatment. We can take a sample of your DNA by asking you to rub the inside of your cheek with a cotton bud. Later in the research we will test whether the genes from all adolescents we have scanned are associated with brain differences. If you do not want to give us DNA, then that is fine. You can still take part in the scanning. We also would like to store your DNA so that we can use it for future studies. The Institute of Psychiatry keeps a large databank of brain imaging data and of DNA/gene data. This is for future studies in order to investigate whether specific genes are associated with specific problems in the general population. For this, all your DNA data will be completely de-anonimised. This means that your name will be stripped off of your DNA and it will not be possible to go back and find out whether the DNA came from you or from another adolescent. We will also ask you as well as your mum, dad or carer to fill in some questionnaires about your behaviour and do an IQ test. You will also meet with a psychiatrist who will talk with you and your mum/dad/carer more about your behaviour and about the child abuse. You will be able to talk to the psychiatrist if you become upset about anything and you may stop the research at any time you wish. We will also ask you to do a urine test to check whether there are any drugs in your body. If we find that you have taken drugs recently you will not be able to continue with the study but you will be given the opportunity to talk to the clinical psychiatrist about your drug use. If drugs are found in your urine you will be referred to a suitable service for help, and in this case your confidentiality will be broken.If you and the psychiatrist feel you need help for your drug use you will be referred to a suitable organisation. We will inform your GP that you are participating in this research. We will also ask you to give us permission to contact social services to look into your records. What exactly will happen to me on the day of the research scan? We will ask you to come and see us at the Institute of Psychiatry, where you will do the IQ test and fill in some questionnaires and where your mum or dad or carer will also fill in some questionnaires about your behaviour. You will then meet with the psychiatrist who will talk with you and your mum/dad/carer separately about your behaviour. All information you give us will be kept confidential and we will not tell anybody, not even your mum/dad/carer about what you are telling us. We will then use a laptop to show you the computer games you will be doing in the scanner: they are simple games where you have to stop or change what you are doing or concentrate for a small amount of time. You will then be in the scanner for 1.5 hrs. We will then ask you for a DNA sample by asking you to rub some cotton wool on the inside of your cheek. You will also be asked to do a simple urine test to check for drug use. Is the scanner safe and are there any side effects? The scanner uses a big magnet, which reads signals coming from your brain and with that it can measure the activity in your brain. This method is very safe and does not hurt or change anything about you. This magnet does however pull at some things that are made of metal. You cannot have a scan if you have ever had metal in your eyes, or had objects made of metal, like clips, put into your body in an operation, or if you have ever received a gun injury, or if you have ever had a heart pacemaker (an


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electronic object that controls the speed of your heart beat). You cannot take anything that may be attracted to the magnet into the room where the scanner is. You can leave your coins, keys, watches or any thing else that may be attracted to the magnet in a locker, or with your mum/dad/carer. Also, some adolescents do not like small, closed spaces. If you don’t like small, closed spaces you may not like to take part in this research. Each scan is carried out by experienced men and women called radiographers who do lots and lots of scans on boys just like you and they are there to make sure that you are okay. There is nothing special you need to do before or after the scan and you can eat and drink as normal. However, if you have ADHD and take stimulant medication, we will ask you to not take your medication for 24 hours before the scan. There will also be a neurologist who will check for any neurological abnormalities in the brain scan. In the unlikely event that anything abnormal will be found on your brain scan, the neurologist will contact your GP to inform him about this and inform the psychiatrist and the psychiatrist or neurologist will be available to discuss this with you. A letter will be sent to your GP, followed up with a phone call to ensure that they are aware of the seriousness of the findings.

Because we want the pictures of your brain to be very good we need you to lie as still as you can in the scanning machine. The scanner makes rather loud banging noises, but we will give you headphones that make the noise much less loud. There is a mike inside the scanner so that you can talk to us and let us know if you want the scan to stop.

What are the possible disadvantages and risks of taking part? Some adolescents do not like enclosed spaces or are scared of the scanner because it is like a tunnel. If you think that you will find it difficult to go into the scanner, then you should not take part in the study. What is good about taking part? You will not get better or worse after this research. You will get some information about how clever you are and a picture of your brain if you want to. The information we get from this study will help us to understand better what the effect of child abuse has on the human brain in young adolescents. This knowledge will help in the future to develop ways to minimise the negative consequences of early child maltreatment by developing better treatment. What happens when the research stops? When the research study stops you will carry on seeing your doctor as usual. Will the information that is collected about me in this research be kept secret? Anything we find out about you will be kept to ourselves. Any information we have collected from you or about you will be saved in computer files but will be coded and have your name removed so that no one can tell it is you. This applies to any data, including the behavioural questionnaires you have filled in, the brain scan data, or the DNA sample that you have given us. The only exception is when there are concerns about your own safety and well-being, for example in case you are still being abused in any way i.e., physically abused, sexually abused, emotionally abused or neglected, in which case the information you will give us about this will be shared with other agencies such as social services. What will happen to my DNA and brain activity pictures? Once we have your DNA, special scientists will look at it to see if your DNA has any effect on your brain activity. Your DNA and your brain data will be stored in a special storage place at the Institute of Psychiatry where it will be used for future research. However, your name will not be stored with your DNA so it cannot be traced back. The Institute of Psychiatry, within the Biomedical Research Center funded by the National Institute of Health Research (NIHR), has created a huge database for Mental Health which we call a BIOBANK. For this BIOBANK we combine biological data (analyses of genes) and brain imaging data (brain


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scans). The data of all patients who will be scanned at the IOP will be stored in this BIOBANK. Once the BIOBANK has run for 10 or more years it will be possible to study not only single disorders but also the relation between disorders, for instance, between ADHD and depression, from the point of view of brain processes that might be regulated by genes. This may enable development of new and better treatments for psychiatric disorders. All brain imaging and DNA data from you will be kept there, but it will be completely anonymous, this means without your name on it. Once the data are stored, it will be impossible later to go back and determine which of the data came from you and which from other adolescents. What will happen to the results of this research? The results of this study will appear as articles in special magazines that medical doctors and scientists read. If you would like to read the results you can have copies of these articles sent to you by asking Prof Katya Rubia or Dr Heledd Hart. However, your name will not be in any of these magazines and we will only report the differences between the 4 study groups and not mention any individual people. Who is paying for the research? This study has been paid for by the KIDS Company, a charity that looks after adolescents who have problems or who have been abused. Who has checked the research? A special group of people have checked this research to make sure it is okay for you to do. This group of people is called the South London and Maudsley Research Ethics Committee and they have a Code number: XXX Will I get anything for taking part? To thank you for your and your parent/carer’s time we will give your parent/carer £40 to give you for the MRI scan. We will also give you or your mum, dad or carer any bus, taxi or train fare back or some petrol money if you came by car, so that you have no costs. We will also give you a picture of your brain either by email or on photographic paper. At the end of the research we will write you to let you know what we found out after looking at all the information we have collected. Where do I write to? You can write to Dr Heledd Hart or Prof Katya Rubia at the Depatrment of Child and Adolescent Psychiatry, PO85, Institute of Psychiatry, De Crespigny Park, London, SE5 8AF for any more information or you can telephone: 0207 848 0172. (email: [email protected]; [email protected] ).

We would like to thank you for reading all this information.

Information Sheet Adolescent physically abused only Page 1 05/02/201630/06/2011

You are being invited to take part in some research the Institute of Psychiatry, King’s College London. Before you decide to take part you should understand why this research is being done and what you will have to do. Please take the time to read the information carefully and talk about it with your family, friends or doctor if you want to. Ask us if there is anything that you do not understand and take your time in deciding whether or not you want to take part. What is the purpose of the study? The aim of this study is to investigate whether abuse in childhood has an effect on the structure and activity of the brain. We will test this by using a machine called a magnetic resonance imaging (MRI) scanner to make an image of your brain structure and also an image of your brain in action (brain function) while you are concentrating on a task. We want to look at the differences between what goes on inside the brains of adolescents who have been physically abused in the past with what goes on inside the brains of adolescents who have not been physically abused. Since adolescents who have been abused often have behavioural problems (like hyperactivity or depression) we will also compare adolescents with child abuse and behavioural problems with adolescents who have behavioural problems but had no child abuse. We need to do this so that we can be sure that the differences we see are related to the child abuse and not to the behavioural problems. So, there will be 4 groups of adolescents in this study


We will also gather information on specific genes via simple cheek swabs from these 4 groups. This is because studies have shown that specific genes are associated with worse behavioural problems in children with childhood abuse. If we would find that the presence of these genes leads to greater brain abnormalities then we would be able to tell in the future which children need more intensive treatment or more intensive attention based on their gene make-up. We hope that this research will help us to better understand the relationship between early childhood maltreatment and the effects this has on the young brain. This is important as better understanding of the effect of child abuse on the brain may help in the future to develop treatment and hopefully lead to better policies of prevention of child abuse.

Why have I been chosen? We ask you to be part of this research because you are a boy between 14 and 18 years old who belongs to group 1) of the groups mentioned above, i.e. you are an adolescent who has been physically abused in childhood and have no behavioural problems. We will ask 100 boys who belong to either group 1-4 to take part in the study. So when we have finished the study we will be able to compare between the brains of these 4 groups of adolescents to find out what is different between the activity and the structure of the brain in adolescents who have been physically abused and adolescents who have not been abused, controlling for the effects of behavioural problems.

VOLUNTEER INFORMATION SHEET: Adolescent



Study Title: Neuroimaging correlates of childhood abuse

(version 2 of 30/06/2011)

Information Sheet Adolescent Physically Abused only Page 2 05/02/201630/06/2011

2

Do I have to take part? No. It is up to you whether you take part or not. If you do want to take part you will be asked to sign a form to say that you would like to take part. Once you have signed this form, you can still change your mind at any time and you do not have to say why. If you decide to change your mind, this will not affect your treatment in any way. What am I asked to do? We will ask you to participate in a brain scan on a MRI scanner. The brain scan is perfectly safe, does not hurt and no side effects have ever been reported. You will be in the scanner for about 1 hour and 30min. First, we will take a picture of your brain while you are doing nothing. During this time you can watch a movie that you will be able to choose yourself. Then, while you are still in the scanner, you will have to do 4 short computer tests of 10 min each. Below is a picture of the scanner. Please note that you will be lying in the scanner during the entire time with a button box and you will be able to see the screen (shown in the picture) through a mirror that is attached in the ceiling of the scanner. We will show you how this works before you are being scanned on a dummy scanner.


The patterns of these genes are very important in making us who we are. We would also like to take a sample of your DNA so that we can look to see if different patterns of genes are related to the way the brain functions or to the way the brain is built. This is important as it has been shown that specific genes make people more susceptible to brain differences after they have been abused while other people with different genetic make-up are more resilient and remain unaffected by their early life

experience. To find out which genes are associated with susceptibility to brain abnormalities in people with abuse will help us in the future to know which people are in more need of treatment. We can take a sample of your DNA by asking you to rub the inside of your cheek with a cotton bud. Later in the research we will test whether the genes from all adolescents we have scanned are associated with brain differences. If you do not want to give us DNA, then that is fine. You can still take part in the scanning.


3

We also would like to store your DNA so that we can use it for future studies. The Institute of Psychiatry keeps a large databank of brain imaging data and of DNA/gene data. This is for future studies in order to investigate whether specific genes are associated with specific problems in the general population. For this, all your DNA data will be completely de-anonimised. This means that your name will be stripped off of your DNA and it will not be possible to go back and find out whether the DNA came from you or from another adolescent. We will also ask you as well as your mum, dad or carer to fill in some questionnaires about your behaviour and do an IQ test. You will also meet with a psychiatrist who will talk with you and your mum/dad/carer more about your behaviour and about the child abuse. You will be able to talk to the psychiatrist if you become upset about anything and you may stop the research at any time you wish. We will also ask you to do a urine test to check whether there are any drugs in your body. If we find that you have taken drugs recently you will not be able to continue with the study but you will be given the opportunity to talk to the clinical psychiatrist about your drug use. If drugs are found in your urine you will be referred to a suitable organisation for help, and in this case your confidentiality will be broken.If you and the psychiatrist feel you need help for your drug use you will be referred to a suitable organisation. We will inform your GP that you are participating in this research. We will also ask you to give us permission to contact social services to look into your records. What exactly will happen to me on the day of the research scan? We will ask you to come and see us at the Institute of Psychiatry, where you will do the IQ test and fill in some questionnaires and where your mum or dad or carer will also fill in some questionnaires about your behaviour. You will then meet with the psychiatrist who will talk with you and your mum/dad/carer separately about your behaviour. All information you give us will be kept confidential and we will not tell anybody, not even your mum/dad/carer about what you are telling us. We will then use a laptop to show you the computer games you will be doing in the scanner: they are simple games where you have to stop or change what you are doing or concentrate for a small amount of time. You will then be in the scanner for 1.5 hrs. We will then ask you for a DNA sample by asking you to rub some cotton wool on the inside of your cheek. You will also be asked to do a simple urine test to check for drug use. Is the scanner safe and are there any side effects? The scanner uses a big magnet, which reads signals coming from your brain and with that it can measure the activity in your brain. This method is very safe and does not hurt or change anything about you. This magnet does however pull at some things that are made of metal. You cannot have a scan if you have ever had metal in your eyes, or had objects made of metal, like clips, put into your body in an operation, or if you have ever received a gun injury, or if you have ever had a heart pacemaker (an electronic object that controls the speed of your heart beat). You cannot take anything that may be attracted to the magnet into the room where the scanner is. You can leave your coins, keys, watches or any thing else that may be attracted to the magnet in a locker, or with your mum/dad/carer. Also, some adolescents do not like small, closed spaces. If you don’t like small, closed spaces you may not like to take part in this research. Each scan is carried out by experienced men and women called radiographers who do lots and lots of scans on boys just like you and they are there to make sure that you are okay. There is nothing special you need to do before or after the scan and you can eat and drink as normal. There will also be a neurologist who will check for any neurological abnormalities in the brain scan. In the unlikely event that anything abnormal will be found on your brain scan, the neurologist will contact your GP to inform him about this and inform the psychiatrist and the psychiatrist or neurologist will be available to discuss this with you. A letter will be sent to your GP, followed up with a phone call to ensure that


4

they are aware of the seriousness of the findings.


What are the possible disadvantages and risks of taking part? Some adolescents do not like enclosed spaces or are scared of the scanner because it is like a tunnel. If you think that you will find it difficult to go into the scanner, then you should not take part in the study. What is good about taking part? You will not get better or worse after this research. You will get some information about how clever you are and a picture of your brain if you want to. The information we get from this study will help us to understand better what the effect of child abuse has on the human brain in young adolescents. This knowledge will help in the future to develop ways to minimise the negative consequences of early child maltreatment by developing better treatment. What happens when the research stops? When the research study stops you will carry on seeing your doctor as usual. Will the information that is collected about me in this research be kept secret? Anything we find out about you will be kept to ourselves. Any information we have collected from you or about you will be saved in computer files but will be coded and have your name removed so that no one can tell it is you. This applies to any data, including the behavioural questionnaires you have filled in, the brain scan data, or the DNA sample that you have given us. The only exception is when there are concerns about your own safety and well-being, for example in case you are still being abused in any way i.e., physically abused, sexually abused, emotionally abused or neglected, in which case the information you will give us about this will be shared with other agencies such as social services. What will happen to my DNA and brain activity pictures? Once we have your DNA, special scientists will look at it to see if your DNA has any effect on your brain activity. Your DNA and your brain data will be stored in a special storage place at the Institute of Psychiatry where it will be used for future research. However, your name will not be stored with your DNA so it cannot be traced back. The Institute of Psychiatry, within the Biomedical Research Center funded by the National Institute of Health Research (NIHR), has created a huge database for Mental Health which we call a BIOBANK. For this BIOBANK we combine biological data (analyses of genes) and brain imaging data (brain scans). The data of all patients who will be scanned at the IOP will be stored in this BIOBANK. Once the BIOBANK has run for 10 or more years it will be possible to study not only single disorders but also the relation between disorders, for instance, between ADHD and depression, from the point of view of brain processes that might be regulated by genes. This may enable to find new and better treatments for psychiatric disorders. All brain imaging and DNA data from you will be kept there, but it will be completely anonymous, this means without your name on it. Once the data are stored, it will be impossible later to go back and determine which of the data came from you and which from other adolescents. What will happen to the results of this research? The results of this study will appear as articles in special magazines that medical doctors and scientists read. If you would like to read the results you can have copies of these articles sent to you by asking Prof Katya Rubia or Dr Heledd Hart. However, your name will not be in any of these magazines and we will only report the differences between the 4 study groups and not mention any individual people.


5

Who is paying for the research? This study has been paid for by the KIDS Company, a charity that looks after adolescents who have problems or who have been abused. Who has checked the research? A special group of people have checked this research to make sure it is okay for you to do. This group of people is called the South London and Maudsley Research Ethics Committee and they have a Code number: XXX Will I get anything for taking part? To thank you for your and your parent/carer’s time we will give your parent/carer £40 to give you for the MRI scan. We will also give you or your mum, dad or carer any bus, taxi or train fare back or some petrol money if you came by car, so that you have no costs. We will also give you a picture of your brain either by email or on photographic paper. At the end of the research we will write to you to let you know what we found out after looking at all the information we have collected. Where do I write to? You can write to Dr Heledd Hart or Prof Katya Rubia at the Department of Child and Adolescent Psychiatry, PO85, Institute of Psychiatry, De Crespigny Park, London, SE5 8AF for any more information or you can telephone: 0207 848 0172. (email: [email protected]; [email protected] ).


Information Sheet Adolescent Psychiatric Control Page 1 05/02/201630/06/2011

You are being invited to take part in some research the Institute of Psychiatry, King’s College London. Before you decide to take part you should understand why this research is being done and what you will have to do. Please take the time to read the information carefully and talk about it with your family, friends or doctor if you want to. Ask us if there is anything that you do not understand and take your time in deciding whether or not you want to take part. What is the purpose of the study? The aim of this study is to investigate whether abuse in childhood has an effect on the structure and activity of the brain. We will test this by using a machine called a magnetic resonance imaging (MRI) scanner to make an image of your brain structure and also an image of your brain in action (brain function) while you are concentrating on a task. We want to look at the differences between what goes on inside the brains of adolescents who have been physically abused in the past with what goes on inside the brains of adolescents who have not been physically abused. Since adolescents who have been abused often have behavioural problems (like hyperactivity or depression) we will also compare adolescents with child abuse and behavioural problems with adolescents who have behavioural problems but had no child abuse. We need to do this so that we can be sure that the differences we see are related to the child abuse and not to the behavioural problems. So, there will be 4 groups of adolescents in this study



Why have I been chosen? We ask you to be part of this research because you are a boy between 14 and 18 years old who belongs to group 3) of the groups mentioned above, i.e. you are an adolescent who has not been physically abused in childhood but has some behavioural problems. We will ask 100 boys who belong to either group 1-4 to take part in the study. So when we have finished the study we will be able to compare between the brains of these 4 groups of adolescents to find out what is different between the activity and structure of the brain in adolescents who have been physically abused and adolescents who have not been abused, controlling for the effects of behavioural problems.

VOLUNTEER INFORMATION SHEET: Adolescent




(version 2 of 30/06/2011)


2

Do I have to take part? No. It is up to you whether you take part or not. If you do want to take part you will be asked to sign a form to say that you would like to take part. Once you have signed this form, you can still change your mind at any time and you do not have to say why. If you decide to change your mind, this will not affect your treatment in any way. What am I asked to do? We will ask you to participate in a brain scan on a MRI scanner. The brain scan is perfectly safe, does not hurt and no side effects have ever been reported. You will be in the scanner for about 1 hour and 30min. First, we will take a picture of your brain while you are doing nothing. During this time you can watch a movie that you will be able to choose yourself. Then, while you are still in the scanner, you will have to do 4 short computer tests of 10 min each. Below is a picture of the scanner. Please note that you will be lying in the scanner during the entire time with a button box and you will be able to see the screen (shown in the picture) through a mirror that is attached in the ceiling of the scanner. We will show you how this works before you are being scanned on a dummy scanner.


The patterns of these genes are very important in making us who we are. We would also like to take a sample of your DNA so that we can look to see if different patterns of genes are related to the way the brain functions or to the way the brain is built. This is important as it has been shown that specific genes make people more susceptible to brain differences after they have been abused while other people with different genetic make-up are more resilient and remain unaffected by their early life

experience. To find out which genes are associated with susceptibility to brain abnormalities in people with abuse will help us in the future to know which people are in more need of treatment. We can take a sample of your DNA by asking you to rub the inside of your cheek with a cotton bud. Later in the research we will test whether the genes from all adolescents we have scanned are associated with brain differences. If you do not want to give us DNA, then that is fine. You can still take part in the scanning.


3

We also would like to store your DNA so that we can use it for future studies. The Institute of Psychiatry keeps a large databank of brain imaging data and of DNA/gene data. This is for future studies in order to investigate whether specific genes are associated with specific problems in the general population. For this, all your DNA data will be completely de-anonimised. This means that your name will be stripped off of your DNA and it will not be possible to go back and find out whether the DNA came from you or from another adolescent. We will also ask you as well as your mum, dad or carer to fill in some questionnaires about your behaviour and do an IQ test. You will also meet with a psychiatrist who will talk with you and your mum/dad/carer more about your behaviour. You will be able to talk to the psychiatrist if you become upset about anything and you may stop the research at any time you wish. We will also ask you to do a urine test to check whether there are any drugs in your body. If we find that you have taken drugs recently you will not be able to continue with the study but you will be given the opportunity to talk to the clinical psychiatrist about your drug use. If drugs are found in your urine you will be referred to a suitable service for help, and in this case your confidentiality will be broken.If you and the psychiatrist feel you need help for your drug use you will be referred to a suitable organisation. We will inform your GP that you are participating in this research. We will also ask you to give us permission to contact social services to look into your records. What exactly will happen to me on the day of the research scan? We will ask you to come and see us at the Institute of Psychiatry, where you will do the IQ test and fill in some questionnaires and where your mum or dad or carer will also fill in some questionnaires about your behaviour. You will then meet with the psychiatrist who will talk with you and your mum/dad/carer separately about your behaviour. All information you give us will be kept confidential and we will not tell anybody, not even your mum/dad/carer about what you are telling us. We will then use a laptop to show you the computer games you will be doing in the scanner: they are simple games where you have to stop or change what you are doing or concentrate for a small amount of time. You will then be in the scanner for 1.5 hrs. We will then ask you for a DNA sample by asking you to rub some cotton wool on the inside of your cheek. You will also be asked to do a simple urine test to check for drug use. Is the scanner safe and are there any side effects? The scanner uses a big magnet, which reads signals coming from your brain and with that it can measure the activity in your brain. This method is very safe and does not hurt or change anything about you. This magnet does however pull at some things that are made of metal. You cannot have a scan if you have ever had metal in your eyes, or had objects made of metal, like clips, put into your body in an operation, or if you have ever received a gun injury, or if you have ever had a heart pacemaker (an electronic object that controls the speed of your heart beat). You cannot take anything that may be attracted to the magnet into the room where the scanner is. You can leave your coins, keys, watches or any thing else that may be attracted to the magnet in a locker, or with your mum/dad/carer. Also, some adolescents do not like small, closed spaces. If you don’t like small, closed spaces you may not like to take part in this research. Each scan is carried out by experienced men and women called radiographers who do lots and lots of scans on boys just like you and they are there to make sure that you are okay. There is nothing special you need to do before or after the scan and you can eat and drink as normal. However, if you have ADHD and take stimulant medication, we will ask you to not take your medication for 24 hours before the scan. You can see what a scanner looks like in the picture below – you might have seen one on TV. There will also be a neurologist who will check for any neurological abnormalities in the brain scan. In the unlikely event that anything abnormal will be found on your brain scan, the


4

neurologist will contact your GP to inform him about this and inform the psychiatrist and the psychiatrist or neurologist will be available to discuss this with you. A letter will be sent to your GP, followed up with a phone call to ensure that they are aware of the seriousness of the findings.


What are the possible disadvantages and risks of taking part? Some adolescents do not like enclosed spaces or are scared of the scanner because it is like a tunnel. If you think that you will find it difficult to go into the scanner, then you should not take part in the study. What is good about taking part? You will not get better or worse after this research. You will get some information about how clever you are and a picture of your brain if you want to. The information we get from this study will help us to understand better what the effect of child abuse has on the human brain in young adolescents. This knowledge will help in the future to develop ways to minimise the negative consequences of early child maltreatment by developing better treatment. What happens when the research stops? When the research study stops you will carry on seeing your doctor as usual. Will the information that is collected about me in this research be kept secret? Anything we find out about you will be kept to ourselves. Any information we have collected from you or about you will be saved in computer files but will be coded and have your name removed so that no one can tell it is you. This applies to any data, including the behavioural questionnaires you have filled in, the brain scan data, or the DNA sample that you have given us. The only exception is when there are concerns about your own safety and well-being, for example in case you are being abused in any way i.e., physically abused, sexually abused, emotionally abused or neglected, in which case the information you will give us about this will be shared with other agencies such as social services. What will happen to my DNA and brain activity pictures? Once we have your DNA, special scientists will look at it to see if your DNA has any effect on your brain activity. Your DNA and your brain data will be stored in a special storage place at the Institute of Psychiatry where it will be used for future research. However, your name will not be stored with your DNA so it cannot be traced back. The Institute of Psychiatry, within the Biomedical Research Center funded by the National Institute of Health Research (NIHR), has created a huge database for Mental Health which we call a BIOBANK. For this BIOBANK we combine biological data (analyses of genes) and brain imaging data (brain scans). The data of all patients who will be scanned at the IOP will be stored in this BIOBANK. Once the BIOBANK has run for 10 or more years it will be possible to study not only single disorders but also the relation between disorders, for instance, between ADHD and depression, from the point of view of brain processes that might be regulated by genes. This may enable to find new and better treatments for psychiatric disorders. All brain imaging and DNA data from you will be kept there, but it will be completely anonymous, this means without your name on it. Once the data are stored, it will be impossible later to go back and determine which of the data were coming from you and which from other adolescents. What will happen to the results of this research? The results of this study will appear as articles in special magazines that medical doctors and scientists read. If you would like to read the results you can have copies of these articles sent to you by asking Prof Katya Rubia or Dr Heledd Hart. However, your name will not be in any of these


5

magazines and we will only report the differences between the 4 study groups and not mention any individual people. Who is paying for the research? This study has been paid for by the KIDS Company, a charity that looks after adolescents who have problems or who have been abused. Who has checked the research? A special group of people have checked this research to make sure it is okay for you to do. This group of people is called the South London and Maudsley Research Ethics Committee and they have a Code number: XXX Will I get anything for taking part? To thank you for your and your parent/carer’s time we will give your parent/carer £40 to pass onto you for the MRI scan. We will also give you or your mum, dad or carer any bus, taxi or train fare back or some petrol money if you came by car, so that you have no costs. We will also give you a picture of your brain either by email or on photographic paper. At the end of the research we will write you to let you know what we found out after looking at all the information we have collected. Where do I write to? You can write to Dr Heledd Hart or Prof Katya Rubia at the Department of Child and Adolescent Psychiatry, PO85, Institute of Psychiatry, De Crespigny Park, London, SE5 8AF for any more information or you can telephone: 0207 848 0172. (email: [email protected]; [email protected] ).


Information Sheet Parent (Control) Page 1 20/12/2012

Your child is being invited to take part in some research at the Institute of Psychiatry, King’s College London. Before you decide to take part you should understand why this research is being done and what your child will have to do. Please take the time to read the information carefully and talk about it with your family, friends or doctor if you want to. Ask us if there is anything that you do not understand and take your time in deciding whether or not you want to take part. What is the purpose of the study? The aim of this study is to investigate whether abuse in childhood has an effect on the structure and activity of the brain. We will test this by using a machine called a magnetic resonance imaging (MRI) scanner to make an image of your child’s brain structure and also an image of his/her brain in action (brain function) while he is concentrating on a task. We want to look at the differences between what goes on inside the brains of adolescents who have been physically abused in the past with what goes on inside the brains of adolescents who have not been physically abused. Since adolescents who have been abused often have behavioural problems (like hyperactivity or depression) we will also compare adolescents with child abuse and behavioural problems with adolescents who have behavioural problems but had no child abuse. We need to do this so that we can be sure that the differences we see are related to the child abuse and not to the behavioural problems. So, there will be 4 groups of adolescents in this study



Why has my child been chosen? We ask you to be part of this research because your child is between 12 and 20 years old and belongs to group 4) of the groups mentioned above, i.e. is a healthy adolescent who has not been physically abused in childhood and has no behavioural problems. We will ask 100 young people who belong to either group 1-4 to take part in the study. So when we have finished the study we will be able to compare between the brains of these 4 groups of adolescents to find out what is different between the activity and the structure of the brain in adolescents who have been physically abused and adolescents who have not been abused, controlling for the effects of behavioural problems.

VOLUNTEER INFORMATION SHEET: Parent




(Version 3 of 20/12/2012)

Information Sheet Adolescent Control Page 2 20/12/2012

2

Does my child have to take part? No. It is up to you whether to take part or not. If you do want your child to take part, you will be asked to sign a consent form to say that you would like him to take part. Once you have signed this form, you can still change your mind at any time and you do not have to say why. If you decide to change your mind, this will not affect your child’s treatment in any way. What is my child asked to do? We will ask him/her to participate in a brain scan on a MRI scanner. The brain scan is perfectly safe, does not hurt and there have never been reported any side effects. Your child will be in the scanner for about 1 hour and 30min. First, we will take a picture of your child’s brain while he/she is doing nothing. During this time he can watch a movie that he will be able to choose himself. Then, while he is still in the scanner, he will have to do 4 short computer tests of 10 min each. Below is a picture of the scanner. Please note that your child will be lying in the scanner during the entire time with a button box and he/she will be able to see the screen (shown in the picture) through a mirror that is attached in the ceiling of the scanner. We will show him/her how this works before he/she is being scanned on a dummy scanner.

Apart from the scan, we will also ask your child to give us a sample of his DNA. Everybody in the world has molecules that are called DNA. DNA are our genes and they decide everything about us like our hair colour, our eye colour and also our behaviours. Below is a picture of what DNA look like. The patterns of these genes are very important in making us who we are.

We would also like to take a sample of your child’s DNA so that we can look to see if different patterns of genes are related to the way the brain functions or to the way the brain is built. This is important as it has been shown that specific genes make people more susceptible to brain differences after they have been abused while other people with different genetic make-up are more resilient and remain unaffected by their early life experience. To find out which genes are associated with susceptibility to brain abnormalities in people with abuse will help us in the future to know which people are in more need of treatment.

We can take a sample of your child’s DNA by asking him/her to rub the inside of his/her cheek with a cotton bud. Later in the research we will test whether the genes from all adolescents we have scanned are associated with brain differences.


3

If your child does not want to give us DNA, then that is fine. He/she can still take part in the scanning. We also would like to store your child’s DNA so that we can use it for future studies. The Institute of Psychiatry keeps a large databank of brain imaging data and of DNA/gene data. This is for future studies in order to investigate whether specific genes are associated with specific problems in the general population. For this, all DNA data will be completely de-anonimised. This means that your child’s name will be stripped off and it will not be possible to go back and find out whether the DNA came from him/her or from another adolescent. We will also ask you and your child to fill in some questionnaires about his behaviour and will do an IQ test with him/her. You will also meet with a psychiatrist who will talk with you and your child more about his/her behaviour. Your child will be able to talk to the psychiatrist if he/she becomes upset about anything and he/she may stop the research at any time he/she wishes. We will also ask your child to do a urine test to check whether there are any drugs in his body. If we find that your child has taken drugs recently he/she will not be able to continue with the study but will be given the opportunity to talk to the clinical psychiatrist about his/her drug use. If the psychiatrist feels your child needs help for his/her drug use he/she will be referred to a suitable organisation, and in this case confidentiality may need to be broken. We will inform your child’s GP that he/she is participating in this research. We will also ask you to give us permission to contact social services to look into your child’s records. What exactly will happen to my child and I on the day of the research scan? We will ask you and your child to come and see us at the Institute of Psychiatry, where he/she will do the IQ test and fill in some questionnaires and where you will also fill in some questionnaires about his/her behaviour. You will then meet with the psychiatrist who will talk with you and your child separately about his/her behaviour. All information you give us will be kept confidential. We will then use a laptop to show your child the computer games he/she will be doing in the scanner: they are simple games where he/she has to stop or change what he/she is doing or concentrate for a small period of time. Your child will then be in the scanner for 1.5 hrs. We will then ask him/her for a DNA sample by asking him/her to rub some cotton wool on the inside of his/her cheek. He/she will also be asked to do a simple urine test to check for drug use. Is the scanner safe and are there any side effects? The scanner uses a big magnet, which reads signals coming from your child’s brain and with that it can measure the activity in his/her brain. This method is very safe and does not hurt or change

anything about him/her. This magnet does however pull at some things that are made of metal. Your child cannot have a scan if he/she has ever had metal in his/her eyes, or had objects made of metal, like clips, put into his /her body in an operation, or if he/she has ever received a gun injury, or if he/she has ever had a heart pacemaker (an electronic object that controls the speed of heart beat). Your child cannot take anything that may be attracted to the magnet into the room where the scanner is. He/she can leave coins, keys, watches or any thing else that may be attracted to the magnet in a locker, or with you. Also, some adolescents do not like small, closed spaces. If your child doesn’t like small, closed spaces he/she may not like to take part in this research. Each scan is carried out by experienced radiographers who do many scans on young people just like your child and they are there to make sure that he/she is okay. There is nothing special your child needs to do before or after the scan and he/she can eat and drink as normal. There will also be a neurologist who will check for any neurological abnormalities in the brain scan. In the unlikely event that anything abnormal is found on your child’s brain scan, the neurologist will contact his/her GP to inform him/her about this and inform the psychiatrist and the psychiatrist or neurologist will be available to discuss this with you. A letter will be sent to your child’s GP, followed up with a phone call


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to ensure that they are aware of the seriousness of the findings.

Because we want the pictures of your child’s brain to be very good we need him/her to lie as still as possible in the scanning machine. The scanner makes rather loud banging noises, but we will give him/her headphones that make the noise much less loud. There is a mike inside the scanner so that he/she can talk to us and let us know if he wants the scan to stop.

What are the possible disadvantages and risks of taking part? Some adolescents do not like enclosed spaces or are scared of the scanner because it is like a tunnel. If you think that your child will find it difficult to go into the scanner, then he/she should not take part in the study. What is good about taking part?

Your child will not get better or worse after this research. You will get some information about how

clever he/she is and a picture of his/her brain if you want to.

The information we get from this study will help us to understand better what the effect of child abuse

has on the human brain in young adolescents. This knowledge will help in the future to develop ways

to minimise the negative consequences of early child maltreatment by developing better treatment. What happens when the research stops? When the research study stops your child will carry on seeing his/her doctor as usual. Will the information that is collected about my child and I in this research be kept secret? Anything we find out about your child will be kept to ourselves. Any information we have collected from him/her or you will be saved in computer files but will be coded and have your names removed. This applies to any data, including the behavioural questionnaires you have filled in, the brain scan data, or the DNA sample that he/she has given us. The only exception is when there are concerns about your child’s own safety and well-being, for example in case he/she is being abused in any way i.e., physically abused, sexually abused, emotionally abused or neglected, in which case the information he/she will give us about this will be shared with other agencies such as social services. What will happen to my child’s DNA and brain activity pictures? Once we have your child’s DNA, researchers will look at it to see if his/her DNA has any effect on his/her brain activity. Your child’s DNA and brain data will be stored in a special storage place at the Institute of Psychiatry where it will be used for future research. However, his/her name will not be stored with his/her DNA so it cannot be traced back. The Institute of Psychiatry, within the Biomedical Research Centre funded by the National Institute of Health Research (NIHR), has created a huge database for Mental Health which we call a BIOBANK. For this BIOBANK we combine biological data (analyses of genes) and brain imaging data (brain scans). The data of all patients who will be scanned at the IOP will be stored in this BIOBANK. Once the BIOBANK has run for 10 or more years it will be possible to study not only single disorders but also the relation between disorders, for instance, between ADHD and depression, from the point of view of brain processes that might be regulated by genes. This may enable development of new and better treatments for psychiatric disorders. All brain imaging and DNA data from your child will be kept there, but it will be completely anonymous, this means without his/her name on it. Once the data are stored, it will be impossible later to go back and determine which of the data came from your child and which from other adolescents. What will happen to the results of this research? The results of this study will appear as articles in scientific and medical journals. If you would like to read the results you can have copies of these articles sent to you by asking Prof Katya Rubia or Dr Heledd Hart. However, your child’s name will not be in any of these magazines and we will only report the differences between the 4 study groups and not mention any individual people. Who is paying for the research?


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This study has been paid for by the KIDS Company, a charity that looks after adolescents who have problems or who have been abused. Who has checked the research? The London- Fulham Research Ethics Committee have checked this research to make sure it is okay for your child to do. The London- Fulham Research Ethics Com

WhatDoTheyKnow · 2020. 11. 30. · Covering Letter 18 May 2011 Evidence of insurance or indemnity...

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